ENSTILAR .5 mg/g
calcipotriene and betamethasone dipropionate · AEROSOL, FOAM · LEO Pharma Inc.
ENSTILAR is a aerosol, foam containing calcipotriene and betamethasone dipropionate at .5 mg/g, taken topical. Manufactured by LEO Pharma Inc..
Key Facts
- Brand Name
- ENSTILAR
- Generic Name
- calcipotriene and betamethasone dipropionate
- NDC Code (Product)
50222-302- Manufacturer
- LEO Pharma Inc.
- Strength
- .5 mg/g
- Dosage Form
- AEROSOL, FOAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA207589
- Marketing Start
- 10/16/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Enstilar ® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older. Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 12 years and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Shake can prior to using Enstilar Foam. Apply Enstilar Foam to affected areas once daily for up to 4 weeks. The maximum dose should not exceed 60 grams every 4 days. Rub in Enstilar Foam gently. Wash hands after applying the product. Discontinue Enstilar Foam when control is achieved. Enstilar Foam should not be used: with occlusive dressings unless directed by a healthcare provider. on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Enstilar Foam is not for oral, ophthalmic, or intravaginal use. Shake before use. Apply Enstilar Foam to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. Do not use more than 60 grams every 4 days. ( 2 ) Do not use with occlusive dressings unless directed by a healthcare provider. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Conducted in Subjects 18 years and older with Psoriasis The rates of adverse reactions described below were from three randomized, multicenter, vehicle and/or active-controlled clinical trials in adult subjects with plaque psoriasis [see Clinical Studies (14) ] . Subjects applied study product once daily for 4 weeks, and the median weekly dose of Enstilar Foam was 25 grams. Adverse reactions reported in <1% of adult subjects treated with Enstilar Foam included: application site irritation, application site pruritus, fo…
Frequently Asked Questions
What is ENSTILAR used for?
ENSTILAR contains calcipotriene and betamethasone dipropionate. It is a aerosol, foam taken topical. Consult your doctor for specific uses.
Is ENSTILAR a controlled substance?
ENSTILAR is not classified as a controlled substance by the DEA.
What is the generic name for ENSTILAR?
The generic name for ENSTILAR is calcipotriene and betamethasone dipropionate. There are 5 other brand versions of calcipotriene and betamethasone dipropionate.
What is the NDC code for ENSTILAR .5 mg/g?
The NDC (National Drug Code) for ENSTILAR .5 mg/g is 50222-302, listed by LEO Pharma Inc..